Competitive Landscape and Advantages, page-9

all these things you mention are important, but the key to the market is FDA clearance in this case (or approval if PMA is needed). Clearance for device is given for an intended purpose / indication, you can not change that overnight. That's why it it is key to look at these topics, what would it mean to include "moderate stenosis" in the intended purpose/indication for use, what steps do they need to make with the FDA to get at the same level as the competitors? You can't just change the intended purpose of the device overnight without the regulatory authority involved.

That is the way you need to start thinking in this regulatory landscape. You can't simply state with FDA approval you are ahead of the game. This is chess playing at regulatory level. Cautious planning how to enter the market, choosing the right predicate device for the 510K submission and clearance and plan ahead for updates of the algorithm(s) needed. They want to work together with device manufacturers for heart valves? What will they need? Can it be done from Echos? or will they need to be doing this from CT scans? What regulatory hurdles will they need to take for it to bring it to the market? Welcome to the world of medical devices. So all in all: it is not just R&D, partnerships etc., it is the company that can bring a device to the market with good execution of their regulatory strategy.